Three companies involved in kratom supplements have received warnings from the U.S. Food and Drug Administration for illegally selling unapproved drug products containing kratom, not to mention claims that they help in the treatment of opioid addiction and withdrawal, treat pain, and can aid in other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes.
Kratom, derived from the leaves of the Mitragyna Speciosa tree, is natural, just as advocates claim, and unlike almost all supplements it does do something - but what it does is often bad. It is actually a drug and needs to be regulated like any drug. That is where kratom users and trade groups balk. They want to have the veil of medical legitimacy in their marketing claims ("it works") but want none of the rigorous clinical trials that go into proving how effective and safe medicine is, because it is derived from leaves. Not only is it a drug, it is chemically a mixture of psychoactive compounds mitragynine and 7-hydroxymitragynine, and therefore might rightly have been considered a Schedule I substance with no legal use in the US due to high potential for abuse.
So they have gotten off lucky there. But because it is a supplement, and therefore exempt from FDA oversight thanks to President Clinton signing the 1994 Dietary Supplement Health and Education Act of 1994 (DSHEA) it has gotten away with a lot. Yet FDA can still require some limits. And exploiting pain patients during a period of nationwide concern over real pain medicines like opioids is over the line.
“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said FDA Commissioner Scott Gottlieb, M.D. “As we work to combat the opioid epidemic, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects.
The three companies that received warning letters are Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri.
Examples of claims being made by these companies include:
- “Along with helping drug addiction, the health benefits of kratom leaves include their ability to lower blood pressure, relieve pain, boost metabolism, increase sexual energy, improve the immune system, prevent diabetes, ease anxiety, eliminate stress, and induce healthy sleep.”
- “The mood elevation qualities of kratom reduces opiate withdrawal effects.”
- “Kratom, like any other pain killer, relieves temporary or even chronic pain.”
- “This plant can relieve headaches, vascular pain, arthritic pain, muscle pain among others.”
- “Kratom can be used as a remedy for stroke-related ailments and condition as it is a powerful antioxidant that works to reduce neuron damage.”
- “It can . . . help in lowering blood pressure.”
- “Kratom is also said to have elements that control blood sugar level in the body for diabetic patients.”
- “It is said, that kratom is very effective against cancer.”